Pain Managment in Preterm Neonates

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

September 10, 2024

Study Completion Date

October 1, 2024

Conditions
Preterm Neonates Pain ManagmentPreTerm Neonate
Interventions
DRUG

fentanyl

"Intra nasal fentanyl group: will receive intranasal fentanyl using nasal dose of INF is 1.5µg/kg/dose, and typically one dose is given After 5minutes, a second dose could be administrated based on the clinical assessment (maximum two doses per procedure).~Intravenous fentanyl group: will receive intravenous fentanyl 1 µg/kg/dose and typically, one dose is given After 5minutes, a second dose could be administrated based on the clinical assessment maximum two doses per procedure.~Measure MDA Malondialdehyde level as oxidative stress marker in pain response , venous blood sample 0.5 ml will be collected twice, just before and 30 minutes after the procedure.~Monitor adverse events after fentanyl use as apnea cessation of breathing for \>20 s, bradycardia heart rate \< 100 beats/minute, desaturation oxygen saturation \< 80%"

Trial Locations (1)

02

Ainshams Univercity, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT07148882 - Pain Managment in Preterm Neonates | Biotech Hunter | Biotech Hunter